Defining the research category in pediatric Phase I oncology trials
| Autor: | Rebecca Dahl, Pramod M. Lad |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Oncology
Research design medicine.medical_specialty Quality Assurance Health Care Library and Information Sciences Pediatrics Risk Assessment Vulnerable Populations Education Informed consent Internal medicine Neoplasms medicine Vulnerable population Humans Parental Consent Significant risk Child Dose limiting toxicity Clinical Trials Phase I as Topic Dose-Response Relationship Drug business.industry General Medicine Institutional review board Clinical research Research Design Maximum tolerated dose business Ethics Committees Research |
| Zdroj: | Accountability in research. 22(3) |
| ISSN: | 1545-5815 |
| Popis: | Clinical research studies in children are classified by risk into three major categories. These are as follows: a) minimal risk studies, b) more than minimal risk studies but with benefit, and c) studies with minor increase over minimal risk but with no benefit. Pediatric Phase I oncology trials, which are conducted in a highly vulnerable population of severely ill children with cancer, are designed to establish safety and to determine the maximum tolerated dose (MTD), as well as establish dose limiting toxicity (DLT). These types of studies can be associated with significant risk. The research design of such high- risk studies, which comprise short-term treatments with varying doses, is generally not associated with any clinical benefit. Classification of the research category in these pediatric studies poses a special problem for the Institutional Review Board (IRB) with major implications for the consenting process. The challenges associated with the classification of such studies are discussed in this article. |
| Databáze: | OpenAIRE |
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